Circular 4/TT-BYT: Guidelines for Submitting Research Applications to the Ethics Committee

16:29, 10/07/2024

The Ministry of Health has issued Circular 4/TT-BYT regulating the establishment, functions, duties, and powers of the Ethics Council in biomedical research.

According to Circular 4/TT-BYT, the Ethics Committee in Biomedical Research issues guidelines on the requirements for submitting research dossiers for appraisal, providing information requirements, and prescribed forms for researchers. The guidelines include the following contents:

submission of research dossiers sent to ethics committee, 4/TT-BYT

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Name and address of the secretary, staff, or members of the Ethics Committee receiving the dossier or the address of the electronic information portal for online submission (if any).
List of all written documents in the dossier;
Specifications of the documents;
Language of the documents in the dossier;
Number of copies to be submitted;
Deadline for submission concerning the appraisal date;
Method for acknowledging and notifying regarding incomplete dossiers;
Estimated time for announcing the decision after appraisal;
Timeframe to be followed in case the Ethics Committee requires the dossier submitter to supplement information or amend documents;
Appraisal fee for the research dossier (if any);
Procedures for requesting the Ethics Committee to approve amendments to the study protocol or related documents;
Specifications of the documents for recruitment, information provision, and consent to participate in the research.

See the full text of the regulation at Circular 4/TT-BYT, effective from March 15, 2020.

Thu Ba

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